Utrecht Prostate Cohort for Cancer Treatment Intervention Studies and Long-term Evaluation
UPC
1 other identifier
observational
1,500
1 country
2
Brief Summary
Rationale: Prostate cancer is the most common cancer in men worldwide. Survival rates are high due to the typically non-aggressive nature of disease and effective treatments. Radical treatments such as surgery and radiotherapy often cause toxicity and long term side effects. Based on current available literature, the choice for primary therapy for clinically localised prostate cancer has a negative impact on cancer-specific quality of life (QOL). New interventional treatments are being developed. The investigators aim to build a multidisciplinary prostate cancer cohort which will serve as a multi-trial facility for interventional treatment studies. The Trials within Cohorts (TwiCs) design, also known as cohort multiple Randomized Controlled Trial design (cmRCT) will be conducted and as a prospective registry for assessment of long-term safety, performance and effectiveness new treatment interventions. Objective: To set up a cohort that will serve as a multi-trial platform and facilitate evaluation of new interventional treatment for prostate cancer. Study design: Observational, prospective cohort study, according to the 'Trials within Cohorts' (TwiCs) design. Study population: All patients with newly diagnosed histologically proven prostate cancer. Main study parameters/endpoints: Clinical parameters (e.g. co-morbidity, oncological history, symptoms, imaging, technical and treatment data), clinical endpoints (e.g. toxicity, and survival outcomes) and patient reported outcomes (e.g. QOL).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2020
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 3, 2020
CompletedFirst Posted
Study publicly available on registry
January 14, 2020
CompletedStudy Start
First participant enrolled
February 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 5, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 5, 2033
March 5, 2026
January 1, 2026
10 years
January 3, 2020
March 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change from baseline Quality of Life
Assesment of Health-related quality of life in prostate cancer patients undergoing treatment
Up to 10 years after treatment
Occurence of toxicity (adverse events)
All toxicity occurring during or after treatment will be registered according to the Common Terminology Criteria for Adverse Events (CTCAE version 5) and Clavien Dindo classification, for radiotherapy and surgery respectively.
Up to 10 years after treatment
Occurence of disease recurrence/progression
Biochemical prostate specifice antigen (PSA) recurrence/progression and recurrence/progression based on medical imaging
Up to 10 years after treatment
Secondary Outcomes (1)
Survival
Up to 10 years after treatment
Eligibility Criteria
All patients with newly diagnosed histologically proven prostate cancer, referred for radiation treatment to the Radiotherapy Department of the UMC Utrecht or for prostatectomy, watchful waiting or active surveillance to the Urology Department of St. Antonius hospital or the Urology Department of the UMC Utrecht will be eligible to be enrolled in the cohort.
You may qualify if:
- Age ≥ 18 years.
- Patients with newly diagnosed histologically proven prostate cancer, referred for radiation treatment to the Radiotherapy Department of the UMC Utrecht or for prostatectomy, watchful waiting or active surveillance to the Urology Department of St. Antonius hospital or the Urology Department of the UMC Utrecht.
- Informed consent - at least - for use of routinely collected clinical data and to fill out questionnaires.
You may not qualify if:
- Mentally incompetent patients.
- Inability to understand the Dutch language.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UMC Utrechtlead
- St. Antonius Hospitalcollaborator
Study Sites (2)
St. Antonius Hospital
Nieuwegein, Utrecht, 3435CM, Netherlands
University Medical Center Utrecht
Utrecht, Utrecht, 3508GA, Netherlands
Related Publications (1)
Teunissen FR, Willigenburg T, Meijer RP, van Melick HHE, Verkooijen HM, van der Voort van Zyp JRN. The first patient-reported outcomes from the Utrecht Prostate Cohort (UPC): the first platform facilitating 'trials within cohorts' (TwiCs) for the evaluation of interventions for prostate cancer. World J Urol. 2022 Sep;40(9):2205-2212. doi: 10.1007/s00345-022-04092-2. Epub 2022 Jul 21.
PMID: 35861861DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Helena M. Verkooijen, MD, PhD
UMC Utrecht
- PRINCIPAL INVESTIGATOR
Jochem R.N. van der Voort van Zyp, MD, PhD
UMC Utrecht
- PRINCIPAL INVESTIGATOR
Harm H.E. van Melick, MD, PhD
St. Antonius Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of epidmiology
Study Record Dates
First Submitted
January 3, 2020
First Posted
January 14, 2020
Study Start
February 5, 2020
Primary Completion (Estimated)
February 5, 2030
Study Completion (Estimated)
February 5, 2033
Last Updated
March 5, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Study protocol will be submitted for publication in a peer reviewed (international) scientific journal